Dilator/hair implantor device

ABSTRACT

The present invention provides a dilator/hair implanter device comprising a wedge-shaped hollow body, said body having one end for engageably penetrating the scalp of a patient and wherein said body contains hair grafts for implantation into the scalp of said patient. Further provided is a dilator/hair implanter device comprising a body having at least two parts, said body having one end for engageably penetrating the scalp of a patient and wherein said body contains hair grafts for implantation into the scalp of said patient. Also provided are various methods of transplanting hair.

This application is a divisional of application Ser. No. 08/729,950,filed Oct. 15, 1996 now U.S. Pat. No. 5,899,916 which is a CIP of Ser.No. 08/392,107 filed Feb. 22, 1995 abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to the fields of dermatologicsurgery, hair transplantation and medical devices. More specifically,the present invention relates to a novel dilator/hair implantor devicefor use during hair transplantation procedures.

2. Description of the Related Art

Hair transplantation using hair grafts (standard, minigrafts andmicrografts) has increased in popularity in recent years. The goal ofhair transplantation using hairgrafts is to replace scarce or lost hairin one area of the scalp with hair taken from another area. Althoughnumerous descriptions of techniques exist, the procedure is basicallythe same in most instances. Usually, the hair to be transplanted istaken from the back of the head where it is generally in abundance, evenin those individuals with very thin or absent hair elsewhere. This istypically accomplished through removal of a relatively narrow strip ofscalp from that area. As the resulting wound is likewise narrow, it canbe closed by suturing. The resulting scar is minimal and the scar isgenerally well hidden by the surrounding hair. Many tiny hair grafts arethen taken from the strip of scalp, using either a scalpel or a razorblade. These can be micrografts (1-3 hairs), minigrafts (usually 4-6hairs) or standard grafts (up to 4 mm). These hair grafts are implantedinto the desired area of the scalp, usually in front. Alternatively,hair grafts can be obtained by using a punch instrument (either manualor electric) which is a round cutting instrument, analogous to a cookiecutter, and excising hair grafts directly from hair bearing skin fromthe scalp or other hair-bearing regions of the body. These hair graftscan then be directly implanted as standard grafts or cut into smallergrafts, i.e., minigrafts or micrografts as desired. From this point on,the surgical techniques used varies.

There are 50 to 1,000 donor grafts per hair transplant session, whichare implanted into an equal number of recipient sites. Before any hairgraft can be transplanted, a small hole or opening into the scalp mustbe made. Recipient sites can be prepared with a variety of instruments:needles, small blades, or small punches. Appropriate size needles (tocreate microholes) or scalp blades (to create slits), as well as smallskin punches (to create standard holes) have been used in the past byhair transplant surgeons.

Slits or microholes are typically placed between existing hair folliclesor on the periphery of the scalp, performed with sharp scalpel blades orwith 20, 18, 18 Nokor, or 16 Nokor needles. These slits or microholesare sometimes employed in individuals with earlier thinning or previousmicrograft sessions. On the other hand, holes (1 mm to 4 mm in diameter)are sometimes used in individuals with starkly bald scalps or to removebald skin from between plugs. However, the creation of holes, includingthe removal of bald scalp skin is more time consuming. Grafts generallyare ejected, i.e., "pop out of the scalp" more easily from holes thanfrom slits, but compression often results from grafting into slits. Somesurgeons place a small notch at one end of the circle to alter the holeinto an ellipse, sigma shaped or "q" shaped or place a second smallslit, using a small blade, at an angle relative to the initial slit withthe intention of greatly decreasing graft extrusion and compression. Onemay employ slits and holes in different recipient areas in the samepatient, or in subsequent sessions in the same area. Hair graftinsertion is typically performed using forceps or similar graspinginstruments to take hold of the hair graft and push the graft into therecipient slit or hole while avoiding compression of the hair root.

After the cuts in the scalp have been made, some surgeons will theninsert an instrument into the hole in order to dilate the hole, i.e.,use a dilator. Examples of prior art dilators include small diametersolid metal tubes and wooden dowels. The objective when using a dilatoris to facilitate placement of the hair graft which must be gently placedinto the hole in the scalp. Microdilators, by expanding the size ofrecipient sites (holes, slits and microholes) facilitate micrograftplacement, and can be helpful in some hands. Dilators are used to keepthe donor slit or hole open, facilitate graft insertion by stretchingthe recipient site, act as markers for accurate spacing, aid inhemostasis, and prevent missed recipient sites and aid in quantifyingthe number of recipient sites prepared. However, because dilatorsinvolve two additional steps in hair transplantation, i.e., hairplacement and removal prior to graft insertion, many surgeons find theseextra steps time consuming.

Although surgeons have used dilators, it is time consuming for the hairtransplantation surgeon to place the dilators into the scalp and thenremove them. Although dilators save time during the actual placement ofeach graft into its recipient site, overall, the use of the dilators isviewed by many of those having ordinary skill in this art as taking moretime than is desirable. Mainly for this reason, dilators are oftenomitted despite the above advantages.

Eberhard (German Patent No. 1,953,026) discloses a hair implantationdevice. Applicant's invention is an improvement over Eberhard bycombining the necessary actions of cutting, dilating and inserting ofthe tissue into the scalp. Dilation is an important feature of tissuegrafting to, e.g., minimize bleeding, ease the placement of grafts bymaking grafting faster and less traumatic, and prevent subsequentcompression. The wedge design of Applicant's hairplanter is importantfor dilation and for gentle transfer, features not addressed and in someways opposite of what Eberhard designed.

Applicant's device facilitates a gentle transfer of the hair folliclenot necessary with artificial hairs, with efforts to minimize verticaland lateral forces through employment of Applicant's wedge design so atto dilate the recipient site and facilitate a gentle slidingimplantation of graft. By contrast, Eberhard's claims relate toforeign/artificial hair that has different handling and physicalrequirements. This is illustrated clearly by the impaling of theartificial graft which is an integral feature of technique oftransplantation disclosed in Eberhard and the anchor that has nobiological counterpart for tissue transfer. Moreover, Applicant's deviceis not limited structurally to a cylindrically symmetric device like theneedle/cannula system disclosed by Eberhard.

The actual insertion or placement of the hair grafts into the scalp holeor slit is the most difficult and important part of hair transplantsurgery. The prior art is deficient in the lack of simple,cost-effective means of dilating hair graft sites and easily insertinghair grafts during hair transplant surgery. The present inventionfulfills this longstanding need and desire in the art.

SUMMARY OF THE INVENTION

In one embodiment of the present invention, there is provided an articleof manufacture comprising a dilator/hair implanter device comprising anon-cylindrical wedge-shaped hollow body, said body having one endhaving an opening for engageably penetrating a patient's scalp, whereinsaid body has a length of from about 10 mm to about 200 mm, a minimumwidth up to about 4.5 mm and wherein said body has at least one fin-likeelement to facilitate dilation of the implant, said element extending towithin about 0.7 cm of the end of said body that penetrates the scalp.In one embodiment, this wedge is transected or semi-conical in itsconfiguration.

In another embodiment of the present invention, there is provided adilator/hair implanter device comprising a non-cylindrical body havingat least two wedges, said body having one end for penetrating apatient's scalp, wherein said body of each wedge has a length of fromabout 10 mm to about 200 mm, a width minimum of up to about 4.5 mm andwherein said body has at least one fin-like element attached to thedistal end of at least one wedge, said fin-like element extending towithin about 0.7 cm of the end which penetrates the scalp.

In still yet another embodiment of the present invention, there isprovided a method of implanting hair grafts into the scalp of a human,comprising the steps of: placing one or more hair grafts onto the hairtransplanter of the present invention; engaging said scalp with saidtransplanter so as to create and dilate a hole within which to placesaid graft; and inserting said graft into said hole.

In still yet another embodiment of the present invention, there isprovided a dilator/hair implanter device comprising a wedge-shapedhollow body, said body having an inclined plane or inclined surface inits interior aspect and having in one end an opening for engageablypenetrating a patient's scalp, wherein said body has a length of fromabout 10 mm to about 200 mm, a minimum width of up to about 4.5 mm andwhererin said body has at least one fin-like element attached to theproximal end of said body, said fin-like element extending to withinabout 0.7 cm of the end which penetrates the scalp.

Other and further aspects, features, and advantages of the presentinvention will be apparent from the following description of thepresently preferred embodiments of the invention given for the purposeof disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

So that the matter in which the above-recited features, advantages andobjects of the invention, as well as others which will become clear, areattained and can be understood in detail, more particular descriptionsof the invention briefly summarized above may be had by reference tocertain embodiments thereof which are illustrated in the appendeddrawings. These drawings form a part of the specification. It is to benoted, however, that the appended drawings illustrate preferredembodiments of the invention and therefore are not to be consideredlimiting in their scope.

FIG. 1 shows one embodiment of the dilator/hair implantor device of thepresent invention. FIG. 1A shows an embodiment of the dilator/hairimplantor device having short fins. FIG. 1B shows an embodiment of thedilator/hair implantor device having longer fins.

FIG. 2 shows another embodiment of the dilator/hair implantor device ofthe present invention in which the body of the device is comprised oftwo separate semi-conical halves. FIG. 2A shows the dilator/hairimplantor device in the closed position. FIG. 2B shows the dilator/hairimplantor device in the open position.

FIG. 3 shows another embodiment of the present invention comprising abody having at least one lengthwise slot, or alternatively oradditionally, a first lengthwise slot.

FIG. 4 shows two wedges with a compound third class lever (with afulcrum 27).

FIG. 5 shows two wedges with a compound first class lever with leverarms 18 leading to a fulcrum 27 and extending lever arms 31.

FIG. 6 shows two wedges with a third class lever (with a fulcrum 84connected to lever arms 82 that meet at a fulcrum 80 connected to leverarms 18.

FIG. 7 shows a hollow wedge embodiment 50 consisting of an ellipse 52,with laterally oriented and outwardly directed fin elements 54.

FIG. 8 shows a hollow wedge embodiment 60 consisting of a polygon 62with lateral faces 62 and 63 and a top surface 64, having a longitudinalopening 66 and a fin element 67.

FIG. 9 shows the polygonal wedge shaped embodiment with hair grafts 68in place.

FIG. 10 shows the side view of the polygon with an opening tip 76 towhich are attached the lever arms 70 at the fulcrums 72. When the leverarms are pushed towards one another, fulcrums 74 are utilized to enablespreading of the sides 62 and 63.

DETAILED DESCRIPTION OF THE INVENTION

There are many structural and functional differences between the devicesof the present invention and the device disclosed by Eberhard.Functionally, the exterior of Applicant's device can be a wedge in avertical orientation (e.g., a cone) or a polygonal wedge when viewedfrom above (i.e., in horizontal cross sectioning) thereby enhancingdilatation during implantation and spreading. In contrast, Eberhard'sclaim 4 teaches spreading the device only wide enough to permit theinsertion. Eberhard's claim 6 teaches limiting the diameter of thecannula to minimize dilatation while claim 9 teaches arc shapedspreaders as opposed to wedge shaped designs, including fins. In fact,all but the absolutely minimum dilation may be undesirable forartificial hairs because it may result in the hairs falling out assuggested by Eberhard's claim 6. In contrast, Applicant's device andmethods can be utilized to maximize dilatation.

Eberhard's claim 4 relates to an impaling with the anchor using axialforces listed in Eberhard claim 2 that the anchor goes below the pointsof the needles. This is neither possible nor desirable in tissuetransplantation. In contrast, the hollow wedge design of Applicant'sdevice serves to diminish the vertical axis forces, i.e., the oppositegoal Eberhard.

Eberhard does not disclose fins that are equivalent in structure andfunction to the fins on Applicant's device. Eberhard's claims do notteach a fin that impales the scalp but rather a mechanical limitingdevice in association with an adjusting device. In contrast, Applicant'sfins are of a different structure for a completely different function,i.e., dilating the recipient site of the hair graft, or to bemechanically limiting by the fin coming in contact with the skin.

The current device utilizes not just vertical vectors but alsohorizontal ones in the non-obvious utilization of a hollow wedge. Thisdesign combines the features of improved loading and unloading of thetissue graft, through a wedge shaped hollow interior. The inclined planeor inclined surface design of the interior of a hollow wedge wouldfacilitate not only tissue being placed into the device, but also itsbeing deposited into the scalp, acting as a chute at both ends. Inclinedsurface refers to an inclined plane but generalized to account forsloping, curved surfaces such as the interior of a hollow cone.Additionally, the exterior wedge of the present design mechanicallystretches the surrounding recipient tissue to minimize the compressionof the graft (just the opposite of the intent of the artificial hairdevice which seeks to maximize the lateral pressure holding the threadin place). As a result, less vertical pressure is applied as thebiological tissue is inserted into the device and gently pushed down toits recipient site. Furthermore, Applicant's device with slits or adevice in several parts makes a channel wide enough so that a graft canpossibly inserted. In combination with one or more levers, fins, or rodsthat facilitate spreading, Applicant's device creates a wide recipientsite to minimize the vertical forces needed to transfer the graft to thedesired location.

The device of the present invention serves to dilate the donor recipientsite and implant the hair graft into the donor holes simultaneously.Because of its dual action, and ease of use, this device enhances theefficiency of hair transplant procedures using all types of grafts,including standard grafts, and especially mini-grafts and micro-grafts.This device reduces the trauma of implanting the hair grafts, andensures that these grafts are properly oriented (compared with theconventional technique where the shafts may be implanted at undesirableangles). Leaving all of these dilator/implanters in place until all ofthe 50 to 1,000 grafts are transferred facilitates the transplantprocedure since there is less chance of skipping over holes that werecreated or placing two grafts in any one site. Furthermore, this devicewould reduce the chance that the initial grafts placed during atransplant session would be subsequently ejected from recipient holeswhile new grafts are being placed into adjacent holes (which commonlyoccurs during conventional implantation as the new grafts being pushedinto undilated holes exert significant lateral and upward stretchingforces on adjacent scalp skin).

Other advantages of the dilator/hair implantor of the present inventioninclude enabling more grafts to be done during each transplant session,since this device will enable the rate-limiting step of implantation tobe more efficient, as compared with merely using forceps. Also, theenhanced orientation gained by this device enables longer hairs, ratherthan hair shafts that are only two to four millimeters above the skin asare currently used, to be transplanted. This would give the individual amore natural appearance immediately following a halr transplant session.Additionally, this device could potentially enhance the proportion of"graft takes", diminish trauma to the hair graft associated with the useof forceps or similar pushing instruments, diminish compression effectsfound after grafting procedures, and minimize the number of improperlyoriented hairs that can lead to pseudo-folliculitis. None of the priorart tools used to implant hairs have the combined functions of thedilator/hair implantor device of the present invention.

In one embodiment, the dilator/hair implantor device of the presentinvention works on the principles of using a wedge (the exteriorsurface) to serve as a dilator, and an inclined plane (the interiorsurface) for the implantation. Each graft uses one hair transplantdilator/implanter. In one embodiment, there is a thin cone (wedge) whichhas had a plane section removed at an angle relative to its long axis.Thus, hair grafts can be directly placed into the hollow "conical tube"(the inclined plane). The hair graft is placed into this conical tube atthe tip of the transected cone with the subcutaneous tissue (lowest partof the graft) at the bottom and the top oriented towards the cone'sbase. As a wedge, the cone is placed into the scalp recipient site withthe tip down into the recipient scalp (slit or hole) as a dilator, withthe base projecting out of the scalp, serving as an easy marker that ahair has been transferred to the scalp recipient site.

There are advantages to leaving each dilator/hair implanter device inplace until all 50 to 1,000+ grafts have been introduced into the scalp.For example, the dilator/hair implanter of the present invention ensuresa one to one correlation between recipient holes and grafts, andminimizing the "ejection" phenomena described above. Then, after all ofthe dilator/hair implanters have been placed, the surgeon applies gentlepressure to the top of the graft, while pulling the dilator/implanterout of the scalp. As each dilator/implanter is removed, there is asliding "inclined plane" or inclined surface effect between the dilatorand the graft facilitating the device's removal, which completes theimplantation of the grafts.

These dilator/implanters are easily made in different sizes according tothe size of the graft being implanted (one hair to 4.5 millimetergrafts). Additionally, to impede the dilator/implanter from rolling,e.g., on a table while the graft is being placed into it, there areedges on the outside of the cone towards its base, i.e., the part thatdoes not enter the scalp. Furthermore, the dilator/hair implanterdevice, is described in another embodiment, in which a blade like "finor fins" are added to the cone near its tip to make a slit (or slits)adjacent to the cone as it is introduced into a hole. In one embodiment,the fins are triangular wedges having their base attached to the side ofthe device and the tip projected radially outward. This modification ofthe device saves the additional step of creating "small slit or slits"discussed above. The tip of the transected cone may be sharpened, sothat instead of being introduced into a slit or hole, thedilator/implanter could also be pushed into an area of intact scalp tocreate a microhole (or series of slits in combination with the fins)into which it would slide into place to dilate the slit(s) and implantthe hair graft. While the dilator/hair implanter of the presentinvention adequately serves the desired functions listed above, a personhaving ordinary skill in this art would readily be able to make certainrefinements, including determining the optimal dimensions of thesetransected cones as well as which materials should be used (i.e. metalvs. plastic) to optimize the practicality, usefulness, and affordabilityof the dilator/hair implanter of the present invention.

A grafting session in a hair transplantation surgery involves thepreparation and placement of hundreds of grafts. Thus, the value ofeliminating any unnecessary steps is important and easily appreciated bya person having ordinary skill in this art, i.e., generally, adermatalogic or plastic surgeon. The present invention allows the hairtransplant surgeon to make a hole, dilate the hole and subsequentlyplace the graft with a minimum of movements. Furthermore, the presentinvention provides the transplant surgeon with an crucial measure ofcontrol over the angle of insertion of the hair follicle(s). Controlover the angle of insertion of the hair follicle is important to theproper execution of the hair transplant surgical procedure and suchcontrol is mainly lacking in the prior art devices.

Another embodiment of the device utilizes the inclined plane or surface(since with curved interior surfaces, there may be no plane surface, perse, but the equivalent for curved surfaces) for the interior of a hollowwedge to improve the ease of loading hair grafts into the device. Manypractitioners place the individual hair grafts (micrografts, minigrafts,and standard grafts) unto a substance such as TELFA® which has a surfaceto which they are mildly adhesive to facilitate handling of the grafts.One advantage of these surfaces is that they enable one or several hairgrafts to be picked up and placed on the back of the hand in the properorientation, facilitating their handling. Typically, these grafts arethen picked up by forceps (having to be extremely gentle in the transferprocess so as not to exert pressure on the hair producing portion of thefollicles) and placed into the recipients site. Alternatively, if aneedle or cylinder is used for implantation, the grafts are placedeither on the top, or side of the needle that has a slot, or loaded bybeing pushed backwards into the orifice through which they will emerge.

However, needles are by definition slender devices, and are not designedto be wider beyond the distal most portion of the device, often having aconstant diameter (with merely a distal bevel) or being tapered only forthe distal most 1-3 mm. The narrow diameter of a needle has theundesirable effect of making loading of the graft into the device eitherfrom the bottom of a needle into its tiny orifice side (if there is along bevel or slot) or from the top difficult, and often necessitating aseparate element, such as a funnel. However, in this embodiment, theinclined plane of the interior of a hollow wedge enables a biggerrecipient site for inserting the graft into the device, either from theside by adding a longitudinal slot, or else by inserting directly intothe top, compared with the diameter of the needle insertion portion(i.e. the distal approximately 0.6 cm).

One embodiment of the present invention has an opening or longitudinalslot that may of may not be in continuity with the orifice at the end ofthe device that enters the scalp. This opening is made wide enough toallow easy insertion of the hair graft into the device. One way of doingthis is to utilize an inclined plane or inclined surface on the interiorof the device, typically with widening of the interior width beingaccompanied by some degree if not proportional widening of the exteriorwidth as well, with the widening not just at the distal tip that getsinserted into the scalp (approximately 6 mm), if tapering is desired atthis portion of the device, but more proximally as well towards theother end, so that the width of the interior increases to at least 1.2to 2 or more times the width of the device at the proximal most portionof insertion of the device (i.e. about 6 mm). Clearly, a virtualunlimited widening occurs, depending only upon the average angle of theinclined surfaces and the length of the device. Wider interiorsfacilitate not only ease of insertion of single grafts, but alsomultiple grafts, or needles or cylinders containing grafts with thedevice or blades or needles to create holes, with these latterembodiments having the device acting as a sheath (vide infra).

Clearly an inclined surface facilitates top loading of the grafts.Additionally, a longitudinal fissure, slot, or opening can then becreated with a width at least as wide, if not up to several times widerthan the width of the device as it is when it is inserted into the scalp(i.e., if the width of the interior of the device was 1.5 times thewidth of the proximal most portion of the inserted distal portion of thedevice, which can be arbitrarily called 1 mm) then if the openingconsisted of one-half of the surface of the device being removed tohemisection to device in creating the slot, then the interior portion ofthe opening would be 1.5 mm. If the opening were made by removing 90degrees of the surface, then the interior width would be the square rootof two times 0.75 mm, for this example, with lesser angles would have asmaller opening width, while angles greater than 90 but less than 180being wider opening widths. These wide openings would facilitate a mucheasier insertion of the graft (or grafts) as it is being placed into thedevice, as compared with trying to squeeze it into a narrow channel ororifice. Furthermore, if a wedge of fin is placed on at least one edgeof the slot (top, sides or bottom), the wedge or fin can facilitategraft insertion, not only with forceps (where the graft can more easilybe pushed into the slot) but particularly with another method of graftinsertion involving surfaces to which it adheres. In this method, a hairgraft is placed on a TELFA® or other surface to which it mildly adheres.The TELFA® or other surface and graft are then gently pushed over thewedge or fin at the edge of a slot in such a way that the graft isseparated from the surface (analogous to peeling the graft from anadhesive backing), and therefore easily loading the graft (or grafts)into the device.

The advantage of having a slot contiguous with the opening is that itallows a groove by which a device such as a narrow wedge can push thegraft all of the way down the device to the distal end of the devicewhich may be transcected or beveled, with the graft being held down inthe appropriate place on the recipient site while the device is pulledout or extracted from the skin.

As indicated before, there are advantages to having different shapedhollow wedges for different shaped and sized donor grafts and recipientsites, including cone shaped, elliptical, and polygonal. Additionally,the presence of fins can be advantageous not only in loading hair graftsinto the device at the border of one of the edges of the slot or slots,but also in cutting, dilating, etc. As noted above, hard steel andplastics have can be utilized for the device. However, the device canalso have flexible material, such that if there is a plunger used whichis either rigid or has a degree of elasticity which is the size of theinterior of the device proximally, as it goes towards the distal end ofthe device while pushing on the interior walls of the device, the devicebecomes further dilated as the plunger acts as a wedge to expand theinterior of the device. Dilation can also be achieved by having the slothaving a wedge shape with a component of the slot narrowing as itapproaches the distal tip (i.e. the end that enters the scalp), suchthat as a wedge that is the width of the opening proximally is pusheddown distally. Furthermore, the presence of two or more longitudinalslots can enable a pushing wedge (i.e. a needle tip) to be insertedthrough the entire width of the device out the other side, enabling agreater degree of dilation as the pushing wedge is brought down towardsthe distal tip as the graft is being pushed down.

There are settings in which the hollow wedge is utilized after arecipient site is made either by slits or holes or some combination ofthese. As noted previously, the creation of side slits for holes orslits can be extremely valuable, albeit time consuming, in preventingcompression and facilitating dilation. However, a hollow or non-hollowwedge with fins can be initially inserted, thereby creating the desiredrecipient site (i.e., the wedge can be of a solid (or hollow) needledesign (like an 18 gauge needle, for example) that then has a side finthat extends far enough to the tip of the needle that engageblypenetrates the scalp so that a hole with a side slit is created as it isinserted. If the needle is hollow, this could then serve as animplanting device as well, particularly if there is an inclined surfacewith widening of the diameter of the device to facilitate insertion ofthe grafts.

The present invention is also directed to a dilator/hair implanterdevice comprising a non-cylindrical wedge-shaped hollow body, said bodyhaving one end having an opening for engageably penetrating a patient'sscalp, wherein said body has a length of from about 10 mm to about 200mm, a minimum width up to about 4.5 mm and wherein said body has atleast one fin-like element to facilitate dilation of the implant, saidelement extending to within about 0.7 cm of the end of said body thatpenetrates the scalp. Preferably, the body is composed of a materialselected from the group consisting of stainless steel and hard plastic.Flexible materials such as flexible steel can also enhance dilation.Generally, the end having an opening for engageably penetrating apatient's scalp has a sharp edge.

The present invention is also directed to a dilator/hair implanterdevice comprising a non-cylindrical body having at least two wedges,said body having one end for engageably penetrating a patient's scalp,wherein said body of each wedge has a length of from about 10 mm toabout 200 mm, a width minimum of up to about 4.5 mm and wherein saidbody has at least one fin-like element attached to the distal end of atleast one wedge to facilitate dilation of the implant, said fin-likeelement extending to within about 0.7 cm of the proximal end of saidwedge. Preferably, the body is composed of a material selected from thegroup consisting of stainless steel and hard plastic but otherembodiments could use flexible materials such as flexible steel. In oneembodiment, the dilator/hair implanter device has a lever attached toeach part of said body. Preferably, the lever is selected from the groupconsisting of a compound 3^(rd) class lever, a compound 1^(st) classlever, compound 1^(st) class lever having a spring, a first class leverhaving separate fulcrums or a compound 1^(st) class lever attached to acompound 3^(rd) class lever.

The present invention is also directed to a method of implanting hairgrafts into the scalp of a human, comprising the steps of: placing atleast one hair graft onto the dilator/hair implanter device of thepresent invention; engaging said scalp with said dilator/hair implanterdevice so as to create and dilate a hole within which to place saidgraft; and inserting said graft into said hole. Preferably, in oneembodiment, the hair grafts are single hair grafts. It is alsospecifically contemplated that one could use and place in thetransplanter various type of hair grafts, i.e., multiple groups or unitsof grafts taken from the donor area of the scalp at one time, such as arow of hairs that could be inserted simultaneously.

The present invention is also directed to a dilator/hair implanterdevice comprising a wedge-shaped hollow body, said body has a length offrom about 10 mm to about 200 mm, and a minimum width of up to about 4.5mm and said body has an opening for penetrating a patient's scalp; andwherein said body has at least one lengthwise slot, said slot having amaximal width wider than the interior width of the device at a distanceof 0.6 cm from the tip of the device at the end which penetrates thescalp. Preferably, the hollow body has a shape selected from the groupconsisting of cone shaped, elliptical, and polygonal and has an interiorwidth that increases in diameter from the end of the body thatpenetrates the scalp. In one embodiment, the lengthwise slot iscontiguous with the opening of the body. Preferably, the maximum widthof the interior of the body is at least 1.5 times the interior width ofthe body compared with the interior width at a distance of 0.6 cm fromthe tip of which penetrates the patient's scalp. In a preferredembodiment, the body has one or more fins. Preferably, the body is madefrom a material selected from the group consisting of semi-hard plastic,hard plastic, flexible steel and hard steel. In one embodiment, the slothas one or more fins attached to an edge of the slot. In anotherembodiment, the slot has one or more edges having a wedge shape.

The following examples are given for the purpose of illustrating variousembodiments of the invention and are not meant to limit the presentinvention in any fashion.

EXAMPLE 1

The dilator/hair implanter of the present invention allows thetransplant surgeon to: 1) make a hole in the scalp where the graft is tobe placed, 2) dilate the hole; 3) insert the graft into the dilator/hairimplanter of the present invention; and 4) manipulate the graft, withthe tip of a jeweler's forceps or other small instument, down the deviceinto the scalp. The device is then withdrawn while the graft is held inplace. Following withdrawal, the graft should be in its proper position.

FIG. 1 depicts one embodiment of the dilator/hair implanter of thepresent invention. With reference now to FIG. 1, there is shown adilator/hair implanter 2 comprised of a semi-conical, mainly hollow body4. The conical body 4 contains hair shaft 6 having a hair root(s) 8. Thesemi-conical body 4 ends in an extremely sharp tip 10. Further, thesemi-cylindrical body 4 may have a side "fin-like" element(s) 12. The"fin-like" element 12 may extend from the top of body 4 to the tip 10.It is specifically contemplated that the "fin-like" element would bevery sharp so as to allow the surgeon to use the lower aspect of the"fin" to dilate the recipient site.

FIG. 2 illustrates another embodiment of the dilator/hair implanter ofthe present invention in both open and closed variations. With referencenow to FIG. 2A, there is shown a dilator/hair implanter 14 comprised ofa semi-conical, mainly hollow pair of half-bodies 16. The half-body 16has a "lever" 18 attached to the upper aspects of the body 16. Thisdilator/hair implanter also ends in a sharp tip 20 and has a side"fin-like" element 22. The "fin-like" element 12 may extend from the topof body 14 to the tip 20 and the half-body 16 may have more than one"fin" 22. It is again specifically contemplated that the "fin-like"element would be very sharp so as to allow the surgeon to use the loweraspect of the "fin" to dilate the recipient site.

FIG. 2B shows an embodiment of the dilator/hair implanter of the presentinvention in an open configuration. Shown inside the two semi-conicalhalf-bodies is a hair graft 24 comprising a hair shaft 26 having a hairroot 28.

Essentially, the working nature of this embodiment of the dilator/hairimplanter of the present invention is as follows. Using the embodimentof the implanter depicted in FIG. 1, a hair graft is inserted into thecone so that the roots of the graft are towards the tip and the base ofthe shaft is towards the base. This placement of the graft is performedthrough the base using the hollow inside as a chute or else thetransected tip. After the device is inserted into the intact scalp (witha sharp tip and/or fins) or slit or hole, the hair graft slides alongthe hollow inside (incline plane or inclined surface) as the device ispulled out of the scalp. To facilitate the hair graft remaining in thescalp, the graft is held down in the scalp, instead of being forced downas in the prior art techniques such as when using forceps, a cotton tipapplicator, etc.

For the embodiment of the dilator/hair implanter of the presentinvention depicted in FIG. 2, a surgeon places a hair graft into onepart of the semi-cone so that the graft rests on the hollow part withthe root towards the tip and the top of the hair shaft laying towardsthe base by being in an open position. Insertion of the graft into thedilator/hair implanter of the present invention is facilitated. Next,the device is changed to a closed position and inserted into the scalpas described above. Following insertion, the device can be changed to anopen position enhancing dilation of the recipient site as well asfacilitating removal of the device, completing the implantation of thehair graft. The hair graft is held down in the scalp using forceps, acotton tip applicator, etc.

The hair grafts may be placed in the body 4 of the dilator/hairimplanter 2 either before or after insertion of the dilator/hairimplanter 2 into the patient's scalp. Indeed, it is contemplated that ahair transplant surgeon may well desire to load the single hair graftsin the body 4 prior to insertion of the tip 8. In fact, one may desireto load multiple hair grafts, i.e., "stack" the hair grafts onto thedilator/hair implanter 2 prior to insertion of the tip 8.

With reference to FIGS. 1 and 2, the body 4 of the dilator/hairimplanter 2 may be composed of a variety of materials. For example, thebody 4 is fashioned from a stainless steel, such as a stainless steelneedle. It is also contemplated that the body 4 may be composed of othersuitable materials, e.g., hard plastics.

Generally, the size of the body 4 of the dilator/hair implanter 2 isapproximately 18-20 gauge, at an approximate minimum. Thus, the lengthof the body 4 of the dilator/hair implanter 2 is preferably from about10 mm to about 40 mm. Further, the width of the body 4, i.e., thediameter of the dilator/hair implanter of the present invention is fromabout 0.4 mm to about 4.5 mm. Within said semi-conical body 4, it iscontemplated that no more than approximately 270° of the what would havebeen the total cylinder was removed. Furthermore, the width of the "fin"12 in FIG. 1 or "fin" 22 in FIG. 2A would be from about 0.01 mm to about1.5 mm. Generally, the length of the fin 12 in FIG. 1 or "fin" 22 inFIG. 2A would be from about 3 mm to about 40 mm.

The lever 18 of the dilator/hair implanter device of the presentinvention can be selected from a wide variety of levers well known tothose of ordinary skill in this art. Representative example of suitablelever attachments include a compound 3^(rd) class lever, a compound1^(st) class lever, compound 1^(st) class lever having a spring, twofirst class levers having separate fulcrums that are connected or two1^(st) class levers joined by a compound 3^(rd) class lever which couldhave a spring at the fulcrum analogous to a tea bag holder. It isfurther contemplated that one with ordinary skill may desire theadvantage of placing a hook to lock the levers into a closed or openposition A person having ordinary skill in this art would readily beable to substitute one class of lever for another for use in thedilator/hair implanter device of the present invention and be able toachieve essentially the same results. Besides enhanced precision andmechanical advantages that these levers provide, they also facilitateloading hair grafts, dilitation of the recipient sites and removal ofthe device to complete implantation.

The dilator/hair implanter device of the present invention can be usedin conjunction with other hair transplantation devices. For example, aperson having ordinary skill in this art would readily recognize thatvarious injector or injection means may be utilized in conjunction withthe dilator/hair implanter of the present invention.

In yet another embodiment of the present invention, the cone is madewith a fissure along its long axis. This embodiment is made of stainlesssteel having a suitable degree of elasticity. The device would have twopositions, one closed, except having a fissure from one end to the otherlongitudinally; and the other form open, representing a relaxed state ofthe elastic material. The open position would facilitate loading of thehair graft into the device and removal of the device from the scalpfollowing graft placement, analogous to the devided cone of claim 10 inan open position. Through pressing on the sides and possibly locking thedevice with a washer at the base, the device is changed to a closedposition and inserted into the scalp (bald or at recipient holes orslits. It is then changed to the open position, i.e., through removal ofthe washer, thus facilitating removal of the device. In addition tofacilitating the final implantation stage, the device having leversenhances dilitation of the scalp recipient sites.

The device of the present invention may have razor sharp surfacesthroughout all of the exposed edges except the base, i.e., the tip andsides. This enables one to cut off the hair grafts from the hair stripand allows simple loading of the grafts into the device.

Alternatively, the devices of the present invention could harvest graftsdirectly from donor sites on the scalp, i.e., intact scalp or other hairbearing skin, e.g., previously transplanted sites, by being impaled inthe skin, cut out a plug and then transplanting this graft.

Alternatively, the hollow wedge can have other configurations besidesbeing conical including a modified cone which is elliptical rather thanround in cross section. An alternate configuration is a cone that ispolygonal in cross section, somewhat analogous to a pymamid or inhorizontal in cross section similar to a wedge shaped paper holder.Furthermore, it is appreciated by those having ordinary skill in thisart that the inner surface of the semi-cone, divided semi-cone or wedgemay have foci of altered surfaces or tooth-like projections that wouldfacilitate holding the graft(s) in the device of the present inventionand/or its release. Furthermore, these devices described herein may beconnected to one another so that many hair implantation devices areinserted into the scalp simultaneously.

FIG. 3 shows another embodiment of the present invention comprising abody 30 having at least one lengthwise slot 32, or alternatively oradditionally, a first lengthwise slot 34 which is contiguous with theend of the body which penetrates the scalp. Further contemplated is thatthe body 30 may have either a fin 36 oriented vertically or a fin 38oriented horizontally.

Any patents or publications mentioned in this specification areindicative of the levels of those skilled in the art to which theinvention pertains. These patents and publications are hereinincorporated by reference to the same extent as if each individualpublication was specifically and individually indicated to beincorporated by reference.

One skilled in the art will readily appreciate that the presentinvention is well adapted to carry out the objects and obtain the endsand advantages mentioned, as well as those inherent therein. The presentexamples along with any methods, procedures, treatments, molecules, andspecific compounds described herein are presently representative ofpreferred embodiments, are exemplary, and are not intended aslimitations on the scope of the invention. Changes therein and otheruses will occur to those skilled in the art which are encompassed withinthe spirit of the invention as defined by the scope of the claims.

What is claimed is:
 1. A hair graft dilator and insertion apparatuscomprising:a body configured to receive a hair graft therein, said bodypresenting an insertion end; said insertion being beveled to present atip presenting a graft outlet, said body further including wallsdefining a longitudinal slot therein and configured for receiving agraft therethrough into said body, at least a part of said slotpresenting a width of at least about 1.5 times the interior width ofsaid body at a distance of about 0.6 cm from said tip, said body havingone or more outwardly directed, laterally oriented fins, wherein atleast one of said fins is non-arcuate shaped.
 2. The apparatus of claim1, said body having a length of between about 10 mm and 200 mm and aminimum internal width of up to about 4.5 mm.
 3. The apparatus of claim2, wherein at least a portion of said body presents tubularconfiguration.
 4. The apparatus of claim 3, said body including a wallseparating said slot and said graft outlet.
 5. The apparatus of claim 2,said body generally tapering toward said insertion end.
 6. The apparatusof claim 5, at least a portion of said body presenting a generallyconical configuration.
 7. The apparatus of claim 1, at least a part ofsaid slot having a width of at least about 2 times the interior width ofsaid body at a distance of about 6 mm from said tip.
 8. The apparatus ofclaim 1 wherein at least part of the longitudinal edges of the slotconverge toward said insertion end.